Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0095-2017 | 09-13-2016 | mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01. | Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life. | Teva Pharmaceuticals USA / 11,214 vials | Class III | Terminated |
| D-0007-2017 | 09-13-2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86 Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13; 3473357378 | Failed Dissolution Specifications | Sun Pharmaceutical Industries, Inc. / 31,762 bottles | Class III | Terminated |
| D-0117-2017 | 09-13-2016 | Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7 Package NDCs: 51672-1271-1; 51672-1271-2; 51672-1271-3; 51672-1271-7; 51672-1270-1; 51672-1270-2; 51672-1270-3; 51672-1270-7; 51672-1261-1; 51672-1261-2; 51672-1261-3 | Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation). | Taro Pharmaceuticals, Inc. / 6,756 units | Class II | Terminated |
| D-0116-2017 | 09-13-2016 | Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7 Package NDCs: 51672-1271-1; 51672-1271-2; 51672-1271-3; 51672-1271-7; 51672-1270-1; 51672-1270-2; 51672-1270-3; 51672-1270-7; 51672-1261-1; 51672-1261-2; 51672-1261-3 | Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation). | Taro Pharmaceuticals, Inc. / 15,576 units | Class II | Terminated |
| D-0003-2017 | 09-12-2016 | Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK | Lack of Assurance of Sterility; medication was sterilized with a recalled filter | The Apothecary Shoppe LLC / 455 mL total volume | Class II | Terminated |
| D-0004-2017 | 09-12-2016 | Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK | Lack of Assurance of Sterility; medication was sterilized with a recalled filter | The Apothecary Shoppe LLC / 247.5 mL total volume | Class II | Terminated |
| D-0488-2017 | 09-12-2016 | Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles, Rx only, Moore's Pharmacy Compounding, Corpus Christi, TX | Superpotent Drug and Subpotent Drug; potency failures obtained | MOORE'S COMPOUNDING PHARMACY / 90 capsules | Class II | Terminated |
| D-0002-2017 | 09-12-2016 | Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK | Lack of Assurance of Sterility; medication was sterilized with a recalled filter | The Apothecary Shoppe LLC / 419 mL total | Class II | Terminated |
| D-0164-2017 | 09-09-2016 | Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002 | Microbial Contamination of Non-Sterile Product | Cadila Pharmaceuticals Limited / 6.0kg | Class II | Terminated |
| D-0424-2017 | 09-09-2016 | Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34 Package NDCs: 0025-1451-60; 0025-1461-34; 0025-1461-60; 0025-1461-31 | Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months | Pfizer Inc. / 1,706 cartons | Class III | Terminated |
| D-1550-2016 | 09-08-2016 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10 | Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules. | Mckesson Packaging Services / 181 unit cartons of 10 x 10 blister cards | Class III | Terminated |
| D-0217-2017 | 09-08-2016 | GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15 | Defective delivery system: detached needles on the syringe in the kit. | Novo Nordisk Inc / 71,215 kits | Class I | Terminated |
| D-0001-2017 | 09-07-2016 | Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01 Package NDCs: 60635-118-01; 60635-018-01; 60635-133-01; 60635-123-01 | Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack | Biocompatibles U.K., Ltd. / 3,254 administration packs | Class III | Terminated |
| D-0006-2017 | 09-02-2016 | Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10 Package NDCs: 59417-101-10; 59417-102-10; 59417-103-10; 59417-104-10; 59417-105-10; 59417-106-10; 59417-107-10; 59417-115-01; 59417-116-01; 59417-117-01; 59417-118-01; 59417-119-01; 59417-120-01 | Presence of Foreign Tablets/Capsules | Shire / 7,680 bottles (768,000 capsules) | Class III | Terminated |
| D-0499-2017 | 09-02-2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20 | Lack of assurance of sterility | United Exchange Corporation / 190,710 bottles | Class II | Terminated |
| D-0496-2017 | 09-02-2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20 | Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. | United Exchange Corporation / 46,080 bottles | Class I | Terminated |
| D-0214-2017 | 09-02-2016 | Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10. | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | VIRTUS PHARMACEUTICALS OPCO II L / 24,444 bottles | Class I | Terminated |
| D-0213-2017 | 09-02-2016 | Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10. | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | VIRTUS PHARMACEUTICALS OPCO II L / 10,572 bottles | Class I | Terminated |
| D-0498-2017 | 09-02-2016 | Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea, UPC Code: 780707005828 | Lack of assurance of sterility | United Exchange Corporation / 77,184 bottles | Class II | Terminated |
| D-0212-2017 | 09-02-2016 | Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10. | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | VIRTUS PHARMACEUTICALS OPCO II L / 94,643 bottles | Class I | Terminated |
| D-0497-2017 | 09-02-2016 | Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97 | Lack of assurance of sterility | United Exchange Corporation / 112,320 bottles | Class II | Terminated |
| D-0704-2017 | 09-01-2016 | Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01 Package NDCs: 0024-5862-01 | Labeling: Incorrect or Missing Package Insert | Sanofi-Aventis U.S. LLC / 2133 vials | Class III | Terminated |
| D-0118-2017 | 08-30-2016 | Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30. | Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17. | Actavis Laboratories, FL, Inc. / 15,984 bottles | Class III | Ongoing |
| D-0098-2017 | 08-29-2016 | ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81 Package NDCs: 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 3,858 prescription packs (115,680 capsules) | Class III | Terminated |
| D-1486-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-815-25; Blister NDC 68084-815-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 834 cartons | Class II | Terminated |
| D-1487-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-898-32; Blister NDC 68084-898-33 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 126 cartons | Class II | Terminated |
| D-1490-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-887-32; Blister NDC 68084-887-33 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 761 cartons | Class II | Terminated |
| D-1514-2016 | 08-24-2016 | Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540. | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised. | Sandoz Inc / a) 1,584 cartons; b) 62,170 vials | Class II | Terminated |
| D-1513-2016 | 08-24-2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540. | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised. | Sandoz Inc / 32,099 cartons | Class II | Terminated |
| D-1483-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 60687-133-25; Blister NDC 60687-133-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 1,416 cartons | Class II | Terminated |
| D-1485-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 60687-154-25; Blister NDC 60687-154-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 156 cartons | Class II | Terminated |
| D-1482-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-936-25; Blister NDC 68084-936-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 2,276 cartons | Class II | Terminated |
| D-0133-2017 | 08-24-2016 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054 | Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application. | Sandoz Inc / 42,740 cartons (24 count carton from 7 total lots) | Class II | Terminated |
| D-1481-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-874-25; Blister NDC 68084-874-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 221 cartons | Class II | Terminated |
| D-1488-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 666 cartons | Class II | Terminated |
| D-1484-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-943-25; Blister NDC 68084-943-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 867 cartons | Class II | Terminated |
| D-1489-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-909-32; Blister NDC 68084-909-33 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 115 cartons | Class II | Terminated |
| D-1479-2016 | 08-23-2016 | Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06 | Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples. | Stason Pharmaceuticals, Inc. / 17,013 units | Class III | Terminated |
| D-0430-2017 | 08-22-2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. | Noven Pharmaceuticals, Inc. / 357,420 patches | Class II | Terminated |
| D-0429-2017 | 08-22-2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. | Noven Pharmaceuticals, Inc. / 364,830 patches | Class II | Terminated |
| D-0428-2017 | 08-22-2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. | Noven Pharmaceuticals, Inc. / 1,068,600 patches | Class II | Terminated |
| D-1519-2016 | 08-19-2016 | Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05. Package NDCs: 29300-111-01; 29300-111-05; 29300-111-10; 29300-112-01; 29300-112-05; 29300-112-10; 29300-113-16; 29300-113-05; 29300-113-10; 29300-114-16; 29300-114-05; 29300-114-10 | Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets. | Unichem Pharmaceuticals Usa Inc / 368 bottles | Class III | Terminated |
| D-0215-2017 | 08-19-2016 | Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA | Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs | Impax Laboratories, Inc. / 3,074 boxes (30 count boxes) | Class I | Terminated |
| D-1515-2016 | 08-18-2016 | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01, | Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed. | West-Ward Pharmaceuticals Corp. / 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A) | Class III | Terminated |
| D-0216-2017 | 08-16-2016 | Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818 | Non Sterility; contaminated with Klebsiella pneumoniae | Sperian Eye & Face Protection, Inc / 9,744 bottles | Class I | Terminated |
| D-1500-2016 | 08-15-2016 | DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20 | Discoloration: Firm received complaints of product discoloration and particulates. | Hospira Inc. / 24000 vials | Class II | Terminated |
| D-1498-2016 | 08-10-2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605. | Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted. | Allergy Laboratories, Inc. / 1,928,075 vials | Class II | Terminated |
| D-1520-2016 | 08-08-2016 | Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 1,008 bottles | Class II | Terminated |
| D-1522-2016 | 08-08-2016 | Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-033-16. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 1,332 bottles | Class II | Terminated |
| D-1521-2016 | 08-08-2016 | Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-032-16. Package NDCs: 23359-032-16; 23359-032-10; 23359-032-04 | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 5,928 bottles | Class II | Terminated |
| D-1524-2016 | 08-08-2016 | Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 19,656 bottles | Class II | Terminated |
| D-1525-2016 | 08-08-2016 | Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1000-59. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 96,704 bottles | Class II | Terminated |
| D-1526-2016 | 08-08-2016 | Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 68,908 bottles | Class II | Terminated |
| D-1523-2016 | 08-08-2016 | Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1025-47. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 12,308 bottles | Class II | Terminated |
| D-0005-2017 | 08-05-2016 | Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86 | Failed Impurities/Degradation Specifications. | Teva North America / 3,569 capsules | Class III | Terminated |
| D-1501-2016 | 08-04-2016 | buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03 | Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing. | Amerisource Health Services / 2626 bottles | Class III | Terminated |
| D-1518-2016 | 08-04-2016 | Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01 Package NDCs: 0024-5862-01 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Genzyme Corporation / Genzyme Biosurgery / 9,530 vials | Class III | Terminated |
| D-0218-2017 | 08-04-2016 | Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02 Package NDCs: 0409-1159-18; 0409-1159-01; 0409-1159-19; 0409-1159-02; 0409-1160-18; 0409-1160-01; 0409-1162-18; 0409-1162-01; 0409-1162-19; 0409-1162-02; 0409-1163-18; 0409-1163-01; 0409-1165-18; 0409-1165-01; 0409-1165-19; 0409-1165-02; 0409-9043-11; 0409-9043-01; 0409-9046-11; 0409-9046-01; 0409-9045-11; 0409-9045-01; 0409-9045-16; 0409-9045-17; 0409-9042-11; 0409-9042-01; 0409-9042-16; 0409-9042-17 | Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial. | Hospira Inc., A Pfizer Company / 143,250 vials | Class I | Ongoing |
| D-0149-2017 | 08-03-2016 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05 Package NDCs: 68382-354-06; 68382-354-16; 68382-354-05; 68382-354-10; 68382-353-06; 68382-353-16; 68382-353-05; 68382-353-10 | Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point. | Zydus Pharmaceuticals USA Inc / 2,472 units | Class III | Terminated |
| D-1499-2016 | 08-03-2016 | Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90 | Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole. | Aurobindo Pharma USA Inc / 23016 bottles | Class II | Terminated |
| D-1458-2016 | 08-03-2016 | Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS. | Failed Dissolution Specifications: Out-of-specification results in retained sample. | Golden State Medical Supply Inc. / 65,401 bottles | Class II | Terminated |
| D-1459-2016 | 08-03-2016 | Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90 | Failed Dissolution Specifications: Out-of-specification results in retained sample. | Golden State Medical Supply Inc. / 40,631 bottles | Class II | Terminated |
| D-1517-2016 | 08-03-2016 | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60 | Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime. | Reckitt Benckiser LLC / 738 boxes | Class III | Terminated |
| D-1472-2016 | 08-02-2016 | Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61 | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s). | Actavis Inc / 2543 bottles | Class III | Terminated |
| D-1471-2016 | 08-02-2016 | Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82 | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s). | Actavis Inc / 672 bottles | Class III | Terminated |
| D-1456-2016 | 08-01-2016 | Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901 | Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits. | Spectrum Laboratory Products, Inc. / 14,000 grams | Class II | Terminated |
| D-1454-2016 | 08-01-2016 | Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109 | Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes. | Isomeric Pharmacy Solution, LLC / 2,331 vials | Class II | Terminated |
| D-0228-2017 | 08-01-2016 | Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502 | Non-Sterility; microbial contamination identified as Bacillus circulans | Town and Country Compounding and Consultation Services / 12 vials | Class I | Terminated |
| D-0024-2017 | 07-29-2016 | Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials). | CGMP Deviations | Teva Pharmaceuticals USA / 11,844 vials | Class II | Terminated |
| D-0023-2017 | 07-29-2016 | Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials). | CGMP Deviations | Teva Pharmaceuticals USA / 27,547 vials | Class II | Terminated |
| D-0230-2017 | 07-29-2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. Package NDCs: 53462-915-50; 53462-915-51; 53462-915-62; 53462-915-80; 53462-915-81; 53462-915-24; 53462-915-60; 53462-0915-62 | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. | Sage Products LLC / 616,561 cases total | Class II | Terminated |
| D-0231-2017 | 07-29-2016 | 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20. Package NDCs: 53462-705-20; 53462-705-23; 53462-705-26 | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. | Sage Products LLC / 2756 cases | Class II | Terminated |
| D-0229-2017 | 07-29-2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. Package NDCs: 53462-915-50; 53462-915-51; 53462-915-62; 53462-915-80; 53462-915-81; 53462-915-24; 53462-0915-62 | Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. | Sage Products LLC / 576,802 cases total for product codes 7503, 7905, and 7526 | Class I | Terminated |
| D-0209-2017 | 07-28-2016 | C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067 | Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions. | Colonia Care Pharmacy / N/A | Class II | Terminated |
| D-0208-2017 | 07-28-2016 | C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067 | Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions. | Colonia Care Pharmacy / ALL | Class II | Terminated |
| D-1469-2016 | 07-27-2016 | Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60. | Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point | Akorn, Inc. / 4,045 units | Class III | Terminated |
| D-1539-2016 | 07-26-2016 | Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Terminated |
| D-1529-2016 | 07-26-2016 | Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 108 vials | Class II | Terminated |
| D-1541-2016 | 07-26-2016 | Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 8 bottles | Class II | Terminated |
| D-1535-2016 | 07-26-2016 | Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 386606 - 3 vials, 393302 - 3 vials | Class II | Terminated |
| D-1531-2016 | 07-26-2016 | Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Terminated |
| D-1548-2016 | 07-26-2016 | Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 23 vials | Class II | Terminated |
| D-1546-2016 | 07-26-2016 | Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / N/A | Class II | Terminated |
| D-1544-2016 | 07-26-2016 | Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 139 vials | Class II | Terminated |
| D-1530-2016 | 07-26-2016 | Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 5 vials | Class II | Terminated |
| D-1543-2016 | 07-26-2016 | Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 6 vials | Class II | Terminated |
| D-1533-2016 | 07-26-2016 | MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 6 vials | Class II | Terminated |
| D-1537-2016 | 07-26-2016 | Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 14 vials | Class II | Terminated |
| D-1542-2016 | 07-26-2016 | Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 6 vials | Class II | Terminated |
| D-1549-2016 | 07-26-2016 | DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 6 vials | Class II | Terminated |
| D-1540-2016 | 07-26-2016 | Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 36 vials | Class II | Terminated |
| D-1547-2016 | 07-26-2016 | C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 1vial | Class II | Terminated |
| D-1532-2016 | 07-26-2016 | Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml, Rx only, For ophthalmic use only, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Terminated |
| D-1538-2016 | 07-26-2016 | Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 16 vials | Class II | Terminated |
| D-1534-2016 | 07-26-2016 | Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 3 vials | Class II | Terminated |
| D-1545-2016 | 07-26-2016 | C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Terminated |
| D-1536-2016 | 07-26-2016 | Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder / 62 vials | Class II | Terminated |
| D-0219-2017 | 07-25-2016 | Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR | Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia | US Compounding Inc / 10,665 syringes | Class I | Terminated |
| D-0105-2017 | 07-21-2016 | Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distributed by Arbor Pharmaceuticals, LLC Atlanta, GA 30328, NDC 24338-700-10. | Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging. | Arbor Pharmaceuticals Inc. / 16,932 cartons | Class I | Terminated |
| D-1462-2016 | 07-19-2016 | Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu, (m) 20,000 iu with B12, 10 mL sterile, depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247 | Lack of Assurance of Sterility | Talon Compounding Pharmacy / 6,500 vials | Class II | Terminated |
